practical guide to clinical data management third edition

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Practical Guide To Clinical Data Management Third Edition

Author : Susanne Prokscha
ISBN : 9781439848319
Genre : Computers
File Size : 40. 91 MB
Format : PDF
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The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies. See what’s new in the Third Edition: A chapter on the clinical trial process that explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance. Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers.

Practical Guide To Clinical Data Management

Author : Susanne Prokscha
ISBN : 1420007882
Genre : Medical
File Size : 52. 17 MB
Format : PDF, ePub, Mobi
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The management of clinical data, from its collection to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today. Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. Offering specific references to regulations and other FDA documents, it gives guidance on what is required in data handling. Updates to the Second Edition include - A summary of the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures Practices for both electronic data capture (EDC)-based and paper-based studies A new chapter on Necessary Infrastructure, which addresses the expectations of the FDA and auditors for how data management groups carry out their work in compliance with regulations The edition has been reorganized, covering the basic data management tasks that all data managers must understand. It also focuses on the computer systems, including EDC, that data management groups use and the special procedures that must be in place to support those systems. Every chapter presents a range of successful and, above all, practical options for each element of the process or task. Focusing on responsibilities that data managers have today, this edition provides practitioners with an approach that will help them conduct their work with efficiency and quality.

Practical Guide To Clinical Data Management

Author : Susanne Prokscha
ISBN : 1574910434
Genre : Medical
File Size : 45. 73 MB
Format : PDF, Docs
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Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. And clinical data manages have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers you through a basic understanding of the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. This book helps you ensure GCP, manage laboratory data, and deal with the kinds of clinical data that can cause difficulties in database applications. With the tools this book provides, you'll learn how to: Ensure that your DMB system is in compliance with federal regulations Build a strategic data management and databsing plan Track and record CRFs Deal with problem data, adverse event data, and legacy data Manage and store lab data Identify and manage discrepancies Ensure quality control over reports Choose a CDM system that is right for your company Create and implement a system validation plan and process Set up and enforce data collection standards Develop test plans and change control systems This book is your guide to finding the most successful and practical options for effective clinical data management.

Practical Guide To Clinical Data Management

Author : Susanne Prokscha
ISBN : 1574910434
Genre : Medical
File Size : 44. 34 MB
Format : PDF
Download : 543
Read : 528

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Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. And clinical data manages have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers you through a basic understanding of the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. This book helps you ensure GCP, manage laboratory data, and deal with the kinds of clinical data that can cause difficulties in database applications. With the tools this book provides, you'll learn how to: Ensure that your DMB system is in compliance with federal regulations Build a strategic data management and databsing plan Track and record CRFs Deal with problem data, adverse event data, and legacy data Manage and store lab data Identify and manage discrepancies Ensure quality control over reports Choose a CDM system that is right for your company Create and implement a system validation plan and process Set up and enforce data collection standards Develop test plans and change control systems This book is your guide to finding the most successful and practical options for effective clinical data management.

Medical Data Management

Author : Florian Leiner
ISBN : 9780387217734
Genre : Medical
File Size : 89. 30 MB
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Medical Data Management is a systematic introduction to the basic methodology of professional clinical data management. It emphasizes generic methods of medical documentation applicable to such diverse tasks as the electronic patient record, maintaining a clinical trials database, and building a tumor registry. This book is for all students in medical informatics and health information management, and it is ideal for both the undergraduate and the graduate levels. The book also guides professionals in the design and use of clinical information systems in various health care settings. It is an invaluable resource for all health care professionals involved in designing, assessing, adapting, or using clinical data management systems in hospitals, outpatient clinics, study centers, health plans, etc. The book combines a consistent theoretical foundation of medical documentation methods outlining their practical applicability in real clinical data management systems. Two new chapters detail hospital information systems and clinical trials. There is a focus on the international classification of diseases (ICD-9 and -10) systems, as well as a discussion on the difference between the two codes. All chapters feature exercises, bullet points, and a summary to provide the reader with essential points to remember. New to the Third Edition is a comprehensive section comprised of a combined Thesaurus and Glossary which aims to clarify the unclear and sometimes inconsistent terminology surrounding the topic.

A Practical Guide To Managing Clinical Trials

Author : JoAnn Pfeiffer
ISBN : 9781315299778
Genre : Medical
File Size : 45. 41 MB
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A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

A Comprehensive And Practical Guide To Clinical Trials

Author : Delva Shamley
ISBN : 9780128047309
Genre : Medical
File Size : 84. 83 MB
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A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. Describes the entire clinical trial management process from start to finish in a step-by-step guide Provides best practice elements, including case studies, practical examples, activities, and checklists Accompanied by a website with PowerPoint slides and an image bank

Initiating And Sustaining The Clinical Nurse Leader Role A Practical Guide

Author : James L. Harris
ISBN : 9781449659622
Genre : Medical
File Size : 27. 28 MB
Format : PDF, ePub
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Initiating and Sustaining the Clinical Nurse Leader Role: A Practical Approach serves as a practice guide Clinical Nurse Leaders (CNLs) using the ten assumptions for preparing the CNL, the CNL roles, and the end of program competencies. The CNL designs, implements, and evaluates client care by coordinating, delegating and supervising the care provided by the health care team, including licensed nurses, technicians, and other health professionals. This text provides real world tools and processes and includes chapter objectives, summaries, articles, case studies, tools, notes from the field, interviews with CNLs, CNL students, employers of CNLs and educators.

Practical Guide To Clinical Computing Systems

Author : Thomas Payne
ISBN : 9780127999197
Genre : Computers
File Size : 47. 14 MB
Format : PDF, Mobi
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Although informatics trainees and practitioners who assume operational computing roles in their organization may have reasonably advanced understanding of theoretical informatics, many are unfamiliar with the practical topics - such as downtime procedures, interface engines, user support, JCAHO compliance, and budgets - which will become the mainstay of their working lives. Practical Guide to Clinical Computing Systems 2nd edition helps prepare these individuals for the electronic age of health care delivery. It is also designed for those who migrate into clinical computing operations roles from within their health care organization. A new group of people interested in this book are those preparing for Clinical Informatics board certification in the US. The work provides particular differentiation from the popular first edition in four areas: 40% more content detailing the many practical aspects of clinical informatics. Addresses the specific needs of the Clinical Informatics board certification course – for which it is presently recommended by the ABPM Focus on new tech paradigms including cloud computing and concurrency – for this rapidly changing field. Focuses on the practical aspects of operating clinical computing systems in medical centers rather than abstruse theory. Provides deepened and broadened authorship with a global panel of contributors providing new wisdom and new perspectives - reflecting inclusion of the first edition on the clinical informatics study guide materials. Presents a practical treatment of workday but often unfamiliar issues – downtime procedures, interface engines, user support, JCAHO compliance, and budgets.

A Practical Guide To Quality Management In Clinical Trial Research

Author : Graham Ogg
ISBN : 9780849397226
Genre : Medical
File Size : 28. 18 MB
Format : PDF, ePub, Mobi
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Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a cornerstone of knowledge for establishing a quality system that complies with the relevant regulations. There are many books available that cover how to interpret regulations. Going a step or two further, this book provides practical advice that is useful on a daily basis. The book contains information for various standards including GLPs, GCPs, and GMPs. It gives detailed explanations of how to prepare, update, and maintain SOPs and includes advice on training and development of personnel. Drawing directly on his years of experience, the author delineates a from-the-trenches methodology that creates a value-added quality management system from a business perspective. He provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations. The author's integrated approach and anecdotal style turns technically accurate information into easy reading. The book arms you with tools and concepts that you can use to go beyond regulatory compliance and move into the realm of business quality improvement.

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